Pharmaceutical products and medicines
- Document symbol
- G/LIC/N/3/HKG/27
- Original language
- English
- Published on
- 09/11/2023
Outline of Systems
Q1. Give a brief description of each licensing system as a whole and, with respect to each, reply to the following questions as relevant, placing all of the material with respect to a given system in sequence together, and using cross references as appropriate when elements which have already been described are also present in another system.
Licences are required for import of pharmaceutical products and medicines. These import measures are applied for safety, health, security, or for fulfilment of HKSAR's international obligations. Import licences for these products are issued by the Department of Health under delegation from the Trade and Industry Department.
Purposes and Coverage of Licensing
Q2. Identify each licensing system maintained and state what products, appropriately grouped, are covered.
The import licensing system is intended for the following purposes: Pharmaceutical products and medicines to protect public health
Q3. The system applies to goods originating in and coming from which countries?
The import licensing system applies to products coming from all places.
Q4. Is the licensing intended to restrict the quantity or value of imports, and if not, what are its purposes? Have alternative methods of accomplishing the purposes been considered and if so which? Why have they not been adopted?
The principal objective of the import licensing system is for the protection of public health but not to restrict the quantity or value of imports.
Q5. Cite the law, regulation and/or administrative order under which the licensing is maintained. Is the licensing statutorily required? Does the legislation leave designation of products to be subjected to licensing to administrative discretion? Is it possible for the government (or the executive branch) to abolish the system without legislative approval?
The import licensing system is a statutory requirement maintained under respective Ordinances listed below:
Pharmacy and Poisons Ordinance (Cap. 138)
Import and Export (General) Regulations (Cap. 60A), Import and Export Ordinance (Cap. 60)
Dangerous Drugs Ordinance (Cap.134)
Legislation does not leave designation of product to be subject to licensing to administrative discretion. Any changes to the import licensing system require legislative approval.
Procedures
Q6. For products under restriction as to the quantity or value of imports (whether applicable globally or to a limited number of countries or whether established bilaterally or unilaterally):
Q6.I. Is information published, and where, concerning allocation of quotas and formalities of filing applications for licences? If not, how is it brought to the attention of possible importers? Of governments and export promotion bodies of exporting countries and their trade representatives? Is the overall amount published? The amount allocated to goods from each country? The maximum amount allocated to each importer? How to request any exceptions or derogations from the licensing requirement?
Q6.II. How is the size of the quotas determined: on a yearly, six-monthly or quarterly basis? Are there cases where the size of quota is determined on a yearly basis but licences are issued for imports on a six-monthly or quarterly basis? In the latter case, is it necessary for importers to apply for fresh licence on a six-monthly or quarterly basis?
Q6.III. Are licences allotted for certain goods partly or only to domestic producers of like goods? What steps are taken to ensure that licences allocated are actually used for imports? Are unused allocations added to quotas for a succeeding period? Are the names of importers to whom licences have been allocated made known to governments and export promotion bodies of exporting countries upon request? If not, for what reason? (Indicate products to which replies relate.)
Q6.IV. From the time of announcing the opening of quotas, as indicated in I above, what is the period of time allowed for the submission of applications for licences?
Q6.V. What are the minimum and maximum lengths of time for processing applications?
Q6.VI. How much time remains, at a minimum, between the granting of licences and the date of opening of the period of importation?
Q6.VII. Is consideration of licence applications effected by a single administrative organ? Or must the application be passed on to other organs for visa, note or approval? If so, which? Does the importer have to approach more than one administrative organ?
Q6.VIII. If the demand for licences cannot be fully satisfied, on what basis is the allocation to applicants made? First come, first served? Past performance? Is there a maximum amount to be allocated per applicant and, if so, on what basis is it determined? What provision is made for new importers? Are applications examined simultaneously or on receipt?
Q6.IX. In the case of bilateral quotas or export restraint arrangements where export permits are issued by exporting countries, are import licences also required? If so, are licences issued automatically?
Q6.X. In cases where imports are allowed on the basis of export permits only, how is the importing country informed of the effect given by the exporting countries to the understanding between the two countries?
Q6.XI. Are there products for which licences are issued on condition that goods should be exported and not sold in the domestic market?
Q7. Where there is no quantitative limit on importation of a product or on imports from a particular country:
Q7.a. How far in advance of importation must application for a licence be made? Can licences be obtained within a shorter time-limit or for goods arriving at the port without a licence (for example, owing to inadvertency)?
Application for import licences should be lodged in advance of importation taking into account the processing time. The processing time is two working days for pharmaceutical products and medicines
Q7.b. Can a licence be granted immediately on request?
In exceptional cases, a licence can be granted immediately on request.
Q7.c. Are there any limitations as to the period of the year during which application for licence and/or importation may be made? If so, explain.
There are no limitations as to the period of the year during which application for licence and/or importation may be made.
Q7.d. Is consideration of licence applications effected by a single administrative organ? Or must the application be passed on to other organs for visa, note or approval? If so, which? Does the importer have to approach more than one administrative organ?
Department of Health is the sole administrative organ for the processing and approval of import licences.
Q8. Under what circumstances may an application for a licence be refused other than failure to meet the ordinary criteria? Are the reasons for any refusal given to the applicant? Have applicants a right of appeal in the event of refusal to issue a licence and, if so, to what bodies and under what procedures?
Under normal circumstances, an application for an import licence is usually granted if it meets the ordinary criteria. Reasons for refusal will be given to the applicant. Applicants may appeal to the Chief Executive of the HKSAR in the event of refusal to issue an import licence. The Chief Executive may confirm, vary or reverse the decision of the Director‑General of Trade and Industry. The right to appeal to the Chief Executive is provided in relevant statutes.
Eligibility of Importers to Apply for Licence
Q9. Are all persons, firms and institutions eligible to apply for licences: (If not, is there a system of registration of persons or firms permitted to engage in importation? What persons or firms are eligible? Is there a registration fee? Is there a published list of authorized importers?) a) under restrictive licensing systems? b) under non-restrictive systems?
For pharmaceutical products and medicines, only those products which have been registered with the Pharmacy and Poisons Board are allowed to be imported for the purpose of local sale or distribution. A company is required to hold an appropriate dealer's licence issued by the Pharmacy and Poisons Board before it can apply for an import licence. Application for the dealer's licence is open to all business enterprises dealing in pharmaceutical products and medicines. A fee is charged for the licence, which may range from HK$625 to HK$2,680 depending on the type of licence. There is a published list of licensed wholesale dealers and manufacturers in the Drug Office website: http://www.drugoffice.gov.hk.
Documentational and Other Requirements for Application for Licence
Q10. What information is required in applications? Submit a sample form. What documents is the importer required to supply with the application?
What information is required in applications?
In general, information to be supplied includes particulars of the importer, of the importation and of the products to be imported. Sample of the
Import Licence Form 3
https://www.tid.gov.hk/english/aboutus/form/sampleform/files/tra187.pdf
Certain documents are also required to support licence applications of the following products:
A copy of valid trader's licence issued by the Pharmacy and Poisons Board
An import certificate issued under Cap. 134 when dangerous drugs are involved
Q11. What documents are required upon actual importation?
Generally, the import licence is the document required upon actual importation. In addition to the import licence, if the importation involves dangerous drugs, an import certificate and a valid export authorization or diversion certificate issued by the overseas health authority of the exporting country, if applicable, are also documents required to be accompanied with the consignment upon actual importation.
Q12. Is there any licensing fee or administrative charge? If so, what is the amount of the fee or charge?
No licensing fee or administrative charge is required for import licence applications.
Q13. Is there any deposit or advance payment requirement associated with the issue of licences? If so, state the amount or rate, whether it is refundable, the period of retention and the purpose of the requirement.
No deposit or advance payment is required.
Conditions of Licensing
Q14. What is the period of validity of a licence? Can the validity of a licence be extended? How?
Unless otherwise stated, an import licence is valid for six months. The period of validity can be extended by the Director General of Trade and Industry depending on the merits of individual requests.
Q15. Is there any penalty for the non-utilization of a licence or a portion of a licence?
There is no penalty for non-utilization. Importers should however cancel or amend the licences.
Q16. Are licences transferable between importers? If so, are any limitations or conditions attached to such transfer?
The licence is not transferable.
Q17. Are any other conditions attached to the issue of a licence? a) for products subject to quantitative restriction? b) for products not subject to quantitative restriction?
The licensing conditions are printed on the front or back of the import licences
Samples of the Import Licence Form 3 (for pharmaceutical products and medicines) are available at:
Import Licence Form 3
https://www.tid.gov.hk/english/aboutus/form/sampleform/files/tra187.pdf
Other Procedural Requirements
Q18. Are there any other administrative procedures, apart from import licensing and similar administrative procedures, required prior to importation?
A removal licence which is issued free of charge by the Department of Health in pursuance of the Dangerous Drugs Ordinance, Cap. 134, is required for the removal of the dangerous drugs in transit specified therein in such manner and at such time as may be specified therein.
A diversion licence which is issued free of charge by the Department of Health in pursuance of the Dangerous Drugs Ordinance, Cap. 134, is required for the person named therein to divert the dangerous drug in transit specified therein to such country as may be specified therein.
Q19. Is foreign exchange automatically provided by the banking authorities for goods to be imported? Is a licence required as a condition to obtaining foreign exchange? Is foreign exchange always available to cover licences issued? What formalities must be fulfilled for obtaining the foreign exchange?
The banking authorities automatically provide foreign exchange for goods to be imported. No licence is required as a condition to obtaining foreign exchange.